EUCTR2016-001177-32-FR进行中（未招募）1 期
Multicenter Phase II Safety and Preliminary Efficacy Study of 2 dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure. - HEP101
Promethera Biosciences0 个研究点目标入组 12 人开始时间: 2017年3月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult aged between 18 and 70 year old.
- •2. Informed Consent.
- •N.B: In case of hepatic encephalopathy, Informed Consent must be signed by patient’s legal representative according to local regulation, and by the patient, if possible, after encephalopathy improvement.
- •3. Cirrhosis as diagnosed by (1) liver histology or (2) by clinical and imaging examination (may include fibroscan).
- •4. ACLF Grade 1 or ACLF Grade 2 with the following restrictions
- •ACLF grade 1 eligible subset:
- •- liver failure plus cerebral and/or kidney dysfunction
- •- renal failure plus cerebral dysfunction
- •- cerebral failure plus kidney dysfunction
- •- coagulation failure plus cerebral and/or kidney dysfunction
- •ACLF grade 2 eligible subset:
- •Any combination of 2 organ failures including: liver failure, renal failure, cerebral failure, coagulation failure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Absence of portal vein flow as assessed by Doppler ultrasound or other exam.
- •2. Known prothrombotic disease or medical history of thrombotic events.
- •3. Gastrointestinal hemorrhage requiring blood transfusion unless controlled for more than 48h.
- •4. Septic shock or non-controlled bacterial infection defined as persistent clinical signs of infection despite adequate antibiotic therapy for more than 48h.
- •5. Clinical evidence of aspergilus infection.
- •6. Circulatory failure defined as treated with vasoconstrictors to maintain arterial pressure or inotropes to improve cardiac output. N.B: Use of terlipressine to control increased levels of creatinine is not an exclusion criteria.
- •7. Respiratory disordered with pulse oximetry < 93% and related clinical signs, requiring or not mechanical ventilation.
- •8. Treatment with corticosteroids for acute liver disease within 2 weeks before HepaStem infusion.
- •9. MELD score > 35.
- •10. Previous organ transplantation and/or ongoing immunosuppressive treatments.
- •11. Postoperative-decompensation following hepatectomy.
- •12. Renal failure due to chronic kidney disease.
- •13. Clinically significant left-right cardiac shunt.
- •14. Known or suspected hypersensitivity or allergy to any of the components of the HepaStem Diluent (human albumin, heparin sodium and sodium bicarbonate) or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
- •15. Malignancies, other than curatively treated skin cancer, unless a complete remission over 5 years.
- •16. Refusal of abstinence from alcohol for at least 5 weeks from the study enrolment.
- •17. Pregnancy (negative ß-HCG test required) or women with childbearing potential who decline to use reliable contraceptive methods during the study.
- •18. Participation to any other interventional study within the last 4 weeks.
- •19. Any significant medical or social condition or disability that, in the Investigator’s opinion, may warrant a specific treatment, or may interfere with the patient’s optimal participation or compliance with the study procedures.
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